Catalog Number 5531-T-409 |
Device Problems
Break (1069); Fracture (1260); Material Fragmentation (1261); Material Integrity Problem (2978)
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Patient Problems
Occlusion (1984); Injury (2348); Foreign Body In Patient (2687)
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Event Date 02/16/2015 |
Event Type
malfunction
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Event Description
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During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint.The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert he had to pick pieces of plastic out of patients knee joint.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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Conclusions: the reported event was confirmed.Chipping was observed on the distal rails of the triathlon cs insert trial.Scratches and indentations were observed on the articulating surface, underside, and distal rails.The observed damage likely occurred as a result of repeated use.
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Event Description
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During trialing of a triathlon total knee, the surgeon noticed pieces of plastic in knee joint.The surgeon trialed with a 9mm,11mm, and 13mm insert, after he removed each trial insert he had to pick pieces of plastic out of patients knee joint.
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Search Alerts/Recalls
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